In June 2013 the Clinical Research Ethics Committee of the Parc de Salut in Barcelona authorised a "Monitoring Study of Health-Related Quality of Life (HRQoL) amongst Therapeutic Members of Cannabis Clubs and Associations with a Chronic Illness".
The study was an ambitious one. Its aims were to: 1) conduct an approximate census of people using cannabis for medical purposes in Spain; 2) monitor their quality of life; 3) evaluate the safety of medicinal use of cannabis over a period of years; and 4) correlate quality of life variables with various biological parameters such as concentrations of different cannabinoids in hair (an indicator of ingested cannabinoids), certain endocannabinoid neurotransmitters, hormones and the immune system. Unfortunately, we did not achieve the necessary funding to conduct these last three tests. However, we did manage to perform quality of life assessments, take hair samples and, in coming months, we will analyse all the material now at our disposal. Due to poor patient involvement, we were unable to create the intended sample group (200 patients). Furthermore, participant numbers dropped off in the different assessments. Altogether, 7 assessments were performed at intervals of 4 months. In each one, the participants had to complete a series of questionnaires assessing the safety and effectiveness of their cannabis-based treatment. The study concluded on 30 July, 2017. Participation was as follows:
- 1st assessment: 71 subjects
- 2nd assessment: 40 subjects
- 3rd assessment: 25 subjects
- 4th assessment: 19 subjects
- 5th assessment: 9 subjects
- 6th assessment: 4 subjects
- 7th assessment: 3 subjects
Due to the low level of continuation of subjects in the study, it was decided to conduct a sub-study (Sub-study 2) to complement the information gathered in the preliminary study.
The study as originally planned included different scales assessing quality of life and safety of cannabinoid treatment, with different validated questionnaires assessing health-related quality of life (including sleep quality and pain relief) and others assessing treatment safety through monitoring of psychological effects.
The second study, which began in March 2017 and will end on 30 September 2017, will examine a series of health indicators in order to determine the general state of health of patients consuming cannabis for medicinal purposes. These indicators are taken from various health surveys performed in different countries and/or regions, primarily the health surveys of the government (Generalitat) of Catalonia. The aim of this second sub-study is to compare the state of health of medicinal cannabis users with the state of health of the general population of persons with chronic illnesses in Catalonia, with a particular focus on medical and pharmaceutical spending. Several recent studies have shown that many patients replace medication for anxiety and pain with cannabis, and that this has a direct impact on the general healthcare system. It is hoped that the second sub-study will provide local evidence in this regard. Seventy-five patients have already been assessed and the idea is to reach a figure of at least 100. The sub-study will conclude on 30 September 2017.
In conclusion: The study entitled "Monitoring Study of Health-Related Quality of Life (HRQoL) amongst Therapeutic Members of Cannabis Clubs and Associations with a Chronic Illness" has now been completed and the results are being analysed. It will be complemented by a new sub-study entitled "Questionnaire on Health of Medicinal Cannabis Users with Chronic Illnesses". This second study will continue until 30 September 2017. Once the results of the two sub-studies have been gathered, the data will be analysed during the months of October, November and December 2017. At the end of 2017, a complete report will be submitted to the Fundación Canna with the results of the two studies and we will begin writing up the corresponding manuscripts, with the aim of publishing the results in scientific journals from the field of medicinal cannabis and cannabinoid research.